Axillary Reverse Mapping in Preventing Lymphedema in Patients With Breast Cancer Undergoing Axillary Lymph Node Dissection
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03927027 |
|
Recruitment Status :
Recruiting
First Posted : April 25, 2019
Last Update Posted : March 17, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer Stage I Breast Cancer Stage II Breast Cancer Stage III | Drug: Isosulfan Blue Procedure: Axillary Lymph Node Dissection Procedure: Mapping Other: Quality-of-Life Assessment Other: Questionnaire Administration | Phase 3 |
PRIMARY OBJECTIVES:
I. To determine the occurrence of post-surgery lymphedema by conical geometric measures in clinical T1-3, N0-3, M0 breast cancer patients undergoing axillary surgery and randomized to Group 1 (no axillary reverse mapping [ARM]) versus Group II (ARM).
SECONDARY OBJECTIVES:
I. To compare between the study groups the lymphedema symptom intensity and distress as measured by the Lymphedema Symptom Intensity and Distress Survey-Arm (LSIDS-A).
II. To evaluate the technical success of performance of ARM procedure: Identification of ARM lymphatics, and the ability to spare or reapproximate ARM lymphatics.
III. To compare the rate of regional recurrence between patients randomized to receive ARM versus no ARM.
EXPLORATORY OBJECTIVES:
I. To assess the occurrence of lymphedema as a function of radiotherapy use and targets.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive isosulfan blue subcutaneously (SC) and undergo axillary lymph node dissection (ALND).
GROUP II: Patients undergo ARM. Patients then receive isosulfan blue and undergo ALND as in Group I.
After completion of study, patients are followed up for 3 years.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 516 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | ARM: Axillary Reverse Mapping - A Prospective Trial to Study Rates of Lymphedema and Regional Recurrence After Sentinel Lymph Node Biopsy and Sentinel Lymph Node Biopsy Followed by Axillary Lymph Node Dissection With and Without Axillary Reverse Mapping |
| Actual Study Start Date : | May 31, 2019 |
| Estimated Primary Completion Date : | September 2023 |
| Estimated Study Completion Date : | January 2024 |
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Group I (ALND)
Patients receive isosulfan blue SC and undergo ALND.
|
Drug: Isosulfan Blue
Given SC Procedure: Axillary Lymph Node Dissection Undergo ALND
Other Names:
Other: Quality-of-Life Assessment Ancillary studies Other: Questionnaire Administration Ancillary studies |
|
Experimental: Group II (ARM, ALND)
Patients undergo ARM. Patients then receive isosulfan blue and undergo ALND as in Group I.
|
Drug: Isosulfan Blue
Given SC Procedure: Axillary Lymph Node Dissection Undergo ALND
Other Names:
Procedure: Mapping Undergo ARM Other: Quality-of-Life Assessment Ancillary studies Other: Questionnaire Administration Ancillary studies |
- Incidence of upper extremity (UE) lymphedema [ Time Frame: Up to 36 months post surgery ]Will be assessed by the Lymphedema Symptom Intensity and Distress Survey-Arm (LSIDS-A). The LSIDS-A questionnaire contains two different scales for intensity and distress measured from 1 (slight) to 5 (severe). The LSIDS-A questionnaire scores for swelling in the arm, decreased physical activity, pain in the arm, and loss of confidence in one's body will be evaluated for the change of baseline to 36 months using a two-sample, two-sided t-test.
- Change in health-related quality of life: LSIDS-A questionnaire scores [ Time Frame: Baseline to 36 months ]Will be assessed by the Lymphedema Symptom Intensity and Distress Survey-Arm (LSIDS-A). The LSIDS-A questionnaire scores at each time point, as well as the change from baseline will be compared between groups by a two-sample, two-sided t-test. If there is evidence of non-normality (via Shapiro-Wilk testing), will use a non-parametric procedure such as Wilcoxon rank sum test. Further analysis will include linear mixed model using data from all time points to compare the LSIDS-A questionnaire scores between the two treatment groups over time adjusting for other baseline characteristics. Will evaluate the pattern of missing data. If the drop-out rate is higher than expected, methods proposed by Hogan and Laird will be used to assess whether the presence of drop-outs affects inferences obtained from the repeated measures analyses. Appropriate methods will be used to address missingness.
- Incidence of regional recurrence [ Time Frame: Up to 3 years ]The technical success will be summarized using a binomial point estimate and 95% confidence interval (CI) and will be compared using a two-sample test of proportions.
- Technical success of performance of axillary reverse mapping (ARM) procedure (defined as identification of ARM lymphatics, and the ability to spare or reapproximate ARM lymphatics) [ Time Frame: Up to 3 years ]The cumulative incidence of regional recurrence will be summarized using the cumulative incidence function treating death without regional recurrence as the competing risk. Similar analysis methods described for the primary endpoint will be used to compare the cumulative incidence of regional recurrence between group I and II.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
-
Documentation of Disease: cT1-3 patients undergoing axillary surgery who additionally meet one of the following conditions:
- Clinically node negative patients undergoing mastectomy and sentinel lymph node biopsy (SLNB) with possible axillary lymph node dissection (ALND) if SLNB is positive. If ALND is performed during a separate operation, ARM procedure must be repeated. Clinically node negative is defined by i) negative clinical exam and/or ii) negative axillary US and/or iii) negative needle biopsy of sonographically suspicious axillary nodes as applicable to each case.
- Clinically node positive patients as determined by needle biopsy and planned for ALND regardless of type of breast surgery.
- Patients will be staged according to the TNM staging system.
-
Prior Treatment: No prior axillary surgery except needle biopsy or concurrent SLNB.
o Prior neoadjuvant chemotherapy is allowed but must be completed at least 2 weeks before registration.
- No prior history of ipsilateral breast cancer (invasive or ductal breast carcinoma in situ [DCIS]). Lobular breast carcinoma in situ (LCIS) and benign disease are allowed. (May have neoadjuvant chemotherapy which must be completed 2 weeks before registration).
- No bilateral invasive breast cancer.
- No matted nodes.
- No history of lymphedema of either arm.
- No known allergies blue dyes, including make-up containing blue dye.
- In order to complete the mandatory patient-completed measures, participants must be able to speak and/or read English.
- Female :
Men are excluded from this study because the number of men with breast cancer is insufficient to provide a statistical basis for assessment of effects in this subpopulation of people with breast cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
- Creatinine: =< 1.5 x upper limit of normal (ULN).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927027
| Contact: V. Suzanne Klimberg, MD, PhD | 501-680-0779 | Vsklimbe@utmb.edu |
Show 95 study locations
| Study Chair: | V. Suzanne Klimberg, MD, PhD | University of Texas |
| Responsible Party: | Alliance for Clinical Trials in Oncology |
| ClinicalTrials.gov Identifier: | NCT03927027 |
| Other Study ID Numbers: |
A221702 NCI-2018-02445 ( Registry Identifier: NCI Clinical Trial Reporting Program ) UG1CA189823 ( U.S. NIH Grant/Contract ) |
| First Posted: | April 25, 2019 Key Record Dates |
| Last Update Posted: | March 17, 2023 |
| Last Verified: | March 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Breast Neoplasms Lymphedema Neoplasms by Site Neoplasms |
Breast Diseases Skin Diseases Lymphatic Diseases |